Phase 1/2, Drug-Drug Interaction Study of FDL169&FDL176 in HV&CF subs
Research type
Research Study
Full title
A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation
IRAS ID
253727
Contact name
Damian Downey
Contact email
Sponsor organisation
Flatley Discovery Lab, LLC
Eudract number
2018-003468-30
Duration of Study in the UK
0 years, 2 months, 10 days
Research summary
The study drugs, FDL169 and FDL176, are experimental. That means the Medicines and Health Care Regulatory Agency (MHRA) has not approved them for sale or use. FDL169 and FDL176 are being studied to treat Cystic Fibrosis. Cystic Fibrosis is a genetic condition, meaning the patient is born with it, in which the lungs and digestive system can become clogged with thick, sticky mucous. There is currently no cure for Cystic Fibrosis and the average life expectancy for patients who live to adulthood is 41 years.
The aim of the study is to investigate how one study drug affects the other when given at the same time. The safety and how well tolerated the FDL176 study drug is alone and when given with FDL169 will also be investigated. The study will also look at how repeated doses of the study drugs are taken up and broken down by the body.
REC name
HSC REC B
REC reference
18/NI/0178
Date of REC Opinion
18 Oct 2018
REC opinion
Favourable Opinion